BEUDAMED
    FDA Enforcement Class II Terminated

    Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.

    Recall: Z-2053-2015 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-2053-2015
    Event ID
    71474
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 15, 2015
    Initiation Date
    May 29, 2015
    Classification Date
    July 8, 2015
    Termination Date
    March 17, 2016
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.

    Reason

    The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.

    Code Info

    Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019

    Distribution

    Distributed in MA.

    Quantity

    25